Silicone-free glass pre-filled syringe system for Biological Drugs.

Information

  • Research Project
  • 7669963
  • ApplicationId
    7669963
  • Core Project Number
    R43HL092649
  • Full Project Number
    1R43HL092649-01A1
  • Serial Number
    92649
  • FOA Number
    PA-08-050
  • Sub Project Id
  • Project Start Date
    9/15/2009 - 15 years ago
  • Project End Date
    3/14/2011 - 13 years ago
  • Program Officer Name
    MITCHELL, PHYLLIS
  • Budget Start Date
    9/15/2009 - 15 years ago
  • Budget End Date
    3/14/2011 - 13 years ago
  • Fiscal Year
    2009
  • Support Year
    1
  • Suffix
    A1
  • Award Notice Date
    9/14/2009 - 15 years ago
Organizations

Silicone-free glass pre-filled syringe system for Biological Drugs.

DESCRIPTION (provided by applicant): In the medical device industry, silicone oil is a ubiquitous lubricant - used in the manufacture and assembly of components and also as the terminal lubricant for proper device operation. For prefilled syringes, the problem arises when micro-droplets of silicone oil migrate into the drug medium and act as a contaminant and possible reactant for the packaged drug. In the case of biological drugs, such silicone oil contamination has been implicated in protein conformational changes and aggregation. Glass syringes for prefilled applications predominantly use silicone oil as a lubricant. A silicone oil-free glass prefilled device is highly desired, but before it would be accepted, stability testing with various pharmaceutical ingredients as well as particulate and force testing after extended storage is required. We propose the development of glass prefilled syringes with the TriboGlide(r) silicone-free lubrication system based on perfluoropolyether chemistry. The effect of accelerated storage conditions on break-loose and extrusion syringe forces along with comparison of the particulate generation between standard silicone oil lubricated and TriboGlide(r) silicone-free syringes is proposed. In collaboration with the University of Colorado Denver, UCD, TriboGlide(r) syringes will be compared to standard siliconized syringes as devices for packaging of protein formulations. Protein precipitation (UV/Vis spectroscopy), loss of soluble protein (SE-HPLC), influence of adsorbed protein on syringe forces, and pH shifts in water for injection will be assessed. The proteins selected for this study are human serum albumin, human IgG, insulin, and abatecept (monoclonal antibody by Bristol Myers Squibb). In phase II, we propose to evaluate the TriboGlide(r) glass syringes for effects on secondary and tertiary structural changes of the proteins, using circular dichroism and fluorescence spectroscopy. Differential scanning calorimetry will be used to detect changes in the thermodynamic stability of the proteins after extended storage in the syringes. Finally, with the extensive experience in vaccines brought by Dr. LaToya Jones Braun from UCD, we will evaluate the stability of various vaccine formulations stored in the syringes. The medical device and pharmaceutical industries have long desired a completely silicone-free system that does not affect the stability of the packaged drug in solution. If successful, TriboGlide will be the first universal silicone-free system for glass prefilled syringes with applications extending to other medical devices. PUBLIC HEALTH RELEVANCE: Patient controlled self-therapy is a big driving factor for drugs packaged in single-dose prefilled syringe formats for treatment of chronic ailments such as rheumatoid arthritis and diabetes. Other advantages include reduced errors, ease of use, accurate dosage, elimination of preservatives in case of multi-dose vaccines and above all reduced overfill of drugs that are required for packaging in vials. Silicone oil, which serves as a lubricant for easy operation of the syringe, can contaminate the drug product and adversely interact with the sensitive drugs. The proposed TriboGlide system will be the first silicone oil-free system for glass prefilled syringes that overcomes the problems of lubricant migration and drug contamination.

IC Name
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
  • Activity
    R43
  • Administering IC
    HL
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    229475
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    837
  • Ed Inst. Type
  • Funding ICs
    NHLBI:229475\
  • Funding Mechanism
    SBIR-STTR
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    TRIBOFILM RESEARCH, INC.
  • Organization Department
  • Organization DUNS
    115690369
  • Organization City
    RALEIGH
  • Organization State
    NC
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    27606
  • Organization District
    UNITED STATES